safety and efficacy study comparing prodisc-c to acdf surgery to treat scdd

Conditions: Symptomatic Cervical Disc Disease

Summary: the objective of this clinical investigation is to compare the safety and effectiveness of prodisc-c to anterior cervical discectomy and fusion (acdf) surgery in the treatment of symptomatic cervical disc disease (scdd).


Eligibility criteria:
inclusion criteria: * symptomatic cervical disc disease (scdd) in one vertebral level between c3-c7 defined as: neck or arm (radicular) pain; and/or a functional/neurological deficit with at least one of the following conditions confirmed by imaging (ct, mri or x-rays): herniated nucleus pulposus; spondylosis (defined by the presence of osteophytes); and/or loss of disc height. * age between 18 and 60 years. * unresponsive to non-operative treatment for approximately six weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of conservative treatment. * ndi score greater than or equal to 15/50 (30%). * psychosocially, mentally and physically able to fully comply with the protocol including adhering to follow-up schedule and requirements and filling out forms. * signed informed consent. exclusion criteria: * more than one vertebral level requiring treatment. * marked cervical instability on resting lateral or flexion/extension radiographs: translation greater than 3mm and/or greater than 11 degrees of rotational difference to that of either adjacent level. * has a fused level adjacent to the level to be treated. * radiographic confirmation of severe facet joint disease or degeneration. * known allergy to cobalt, chromium, molybdenum, titanium or polyethylene. * clinically comprised vertebral bodies at the affected level(s) due to current or past trauma, e.g. by the radiographic appearance of fracture callus, malunion or nonunion. * prior surgery at the level to be treated. * severe spondylosis at the level to be treated as characterized by any of the following: bridging osteophytes; a loss of disc height greater than 50%; or absence of motion (\<2°). * neck or arm pain of unknown etiology. * osteoporosis: a screening questionnaire for osteoporosis, score (simple calculated osteoporosis risk estimation), will be used to screen patients who require a dexa (dual energy x-ray absoptiometry) bone mineral density measurement. if dexa is required, exclusion will be defined as a dexa bone density measured t score less than or equal to -2.5 (the world health organization definition of osteoporosis). * paget's disease, osteomalacia or any other metabolic bone disease (excluding osteoporosis which is addressed above). * severe diabetes mellitus requiring daily insulin management. * pregnant or interested in becoming pregnant in the next three years. * active infection - systemic or local. * taking medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids). * rheumatoid arthritis or other autoimmune disease. * systemic disease including aids, hiv, hepatitis. * active malignancy: a patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years.

Keywords: prodisc prodisc-c spinal fusion anterior cervical diskectomy cervical spine disc disease implant degenerative disc disease intervertebral disc